Please use this identifier to cite or link to this item: https://doi.org/10.1097/TP.0b013e3182848e03
Title: Randomized trial of everolimus-facilitated calcineurin inhibitor minimization over 24 months in renal transplantation
Authors: Cibrik, D.
Silva Jr., H.T.
Vathsala, A. 
Lackova, E.
Cornu-Artis, C.
Walker, R.G.
Wang, Z.
Zibari, G.B.
Shihab, F.
Kim, Y.S.
Keywords: Calcineurin inhibitor toxicity
Cyclosporine
Everolimus
Renal function
Renal transplantation
Issue Date: 15-Apr-2013
Citation: Cibrik, D., Silva Jr., H.T., Vathsala, A., Lackova, E., Cornu-Artis, C., Walker, R.G., Wang, Z., Zibari, G.B., Shihab, F., Kim, Y.S. (2013-04-15). Randomized trial of everolimus-facilitated calcineurin inhibitor minimization over 24 months in renal transplantation. Transplantation 95 (7) : 933-942. ScholarBank@NUS Repository. https://doi.org/10.1097/TP.0b013e3182848e03
Abstract: BACKGROUND: Strategies allowing calcineurin inhibitor minimization while maintaining efficacy may improve renal transplant outcomes. METHODS: A2309 was a 24-month, phase IIIb, open-label trial of 833 de novo renal transplant recipients randomized to everolimus, targeting trough concentrations of 3-8 or 6-12 ng/mL plus reduced-exposure cyclosporine A (CsA) or to mycophenolic acid (MPA) 1.44 g per day plus standard-exposure CsA. All patients received basiliximab±corticosteroids. The incidence of the primary composite efficacy endpoint and its components (treated biopsy-proven acute rejection, graft loss, death, or loss to follow-up), renal function (serum creatinine and estimated glomerular filtration rate), and adverse events (AEs) were compared at 24 months; as per the protocol, these analyses were not noninferiority. RESULTS: Composite efficacy failure rates (95% confidence interval for difference vs. MPA) were 32.9% (-2.2%, 13.0%), 26.9% (-7.9%, 6.8%), and 27.4% at month 24 in the everolimus 3-8 and 6-12 ng/mL and MPA groups, respectively. Mean estimated glomerular filtration rate (Modification of Diet in Renal Disease) at month 24 was 52.2 (-2.1, 5.5 mL/min/1.73 m), 49.4 (-4.8, 2.7 mL/min/1.73 m), and 50.5 mL/min/1.73 m, respectively. AEs were generally mild to moderate in severity and comparable between the groups. AEs leading to discontinuation were reported in 28.5% (P=0.03 vs. MPA), 30.6% (P=0.007 vs. MPA), and 20.5% of patients receiving everolimus 3-8 and 6-12 ng/mL and MPA, respectively. CONCLUSIONS: Everolimus trough concentrations targeted to 3-8 ng/mL, along with a greater than 60% reduction in CsA exposure, was associated with comparable efficacy and renal function versus MPA plus standard-exposure CsA over the 2-year period. A significantly higher incidence of AEs led to discontinuation in the everolimus groups compared with the MPA group. Copyright © 2013 by Lippincott Williams & Wilkins.
Source Title: Transplantation
URI: http://scholarbank.nus.edu.sg/handle/10635/126842
ISSN: 00411337
DOI: 10.1097/TP.0b013e3182848e03
Appears in Collections:Staff Publications

Show full item record
Files in This Item:
There are no files associated with this item.

SCOPUSTM   
Citations

65
checked on Apr 4, 2020

WEB OF SCIENCETM
Citations

68
checked on Mar 19, 2020

Page view(s)

49
checked on Mar 27, 2020

Google ScholarTM

Check

Altmetric


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.